FDA.reportPublic FDA data

Umcka Menthol

Product NDC
53499-5272
11-digit product format
534995272
Labeler code
53499
Product ID
53499-5272_85ee5b28-643c-448d-ad9e-961f27b2622e
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
2027-07-31
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/120mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka Menthol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3d94c70-3d62-44a8-bdae-39b07e8e0e36Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5272-5Umcka Menthol120 mL in 1 BOTTLE, PLASTICSYRUP12012
53499-5272-5Umcka Menthol1 in 1 CARTONSYRUP112
53499-5272-9Umcka Menthol240 mL in 1 BOTTLE, PLASTICSYRUP24012
53499-5272-9Umcka Menthol1 in 1 CARTONSYRUP112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-5272-5ML - Milliliter53499-52724aa4d383-3cc2-4df3-baf9-8d90618c99fa12025-05-14
53499-5272-9ML - Milliliter53499-52725f5ba943-dd56-4178-b8e3-3e418a334ded12025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5272UMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]11Current NDC, Legacy NDC, 4 package rows20241017_a3d94c70-3d62-44a8-bdae-39b07e8e0e36.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Umcka MentholPELARGONIUM SIDOIDESSchwabe North America, Inca3d94c70-3d62-44a8-bdae-39b07e8e0e362025-11-24WarningsExact identifier
ndc (product): 53499-5272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5272-5534995272051 BOTTLE, PLASTIC in 1 CARTON (53499-5272-5) / 120 mL in 1 BOTTLE, PLASTIC2006-01-012027-07-31NoNoCurrent
53499-5272-9534995272091 BOTTLE, PLASTIC in 1 CARTON (53499-5272-9) / 240 mL in 1 BOTTLE, PLASTIC2006-01-012027-07-31NoNoCurrent